Minneapolis-based Fasikl has acquired FDA 510(ok) clearance for its Felix NeuroAI Wristband for adults with important tremor.
The wearable combines AI and neurotechnology to modulate the nervous system to assist alleviate purposeful limitations attributable to tremors.
The corporate’s AI constantly adjusts stimulation parameters to offer remedy that calms tremors and helps restore motor management.
Fasikl touts that Felix offers reduction for each palms, even when the wearer solely has the wristband on one arm, and might help sufferers with delicate, reasonable and extreme tremors.
“We’re getting into an thrilling new chapter, not only for Fasikl, however for the tens of millions of individuals dwelling with important tremor who’ve lengthy been underserved. Our subsequent step is a targeted business launch of the Felix NeuroAI Wristband, starting in choose U.S. areas in 2025, with a nationwide rollout deliberate for 2026,” Zhi Yang, CEO of Fasikl, instructed MobiHealthNews in an e-mail.
“With Felix, we’re pioneering a brand new class of non-invasive, AI-powered remedy that provides actual, day by day reduction with out the uncomfortable side effects and dangers of medication or surgical procedure. That is just the start of what AI can do in neuromedicine, and we’re excited to convey this remedy to the individuals who want it most.”
THE LARGER TREND
Final 12 months, Fasikl closed a $18.3 million Collection A+ funding spherical co-led by iSeed and Tailwinds Ventures.
In 2023, Fasikl acquired FDA breakthrough system designation for 2 of its choices: MindForce, a nerve-computer interface system designed to permit amputees to regulate robotic limbs utilizing their thoughts, and Epione, an providing meant to alleviate post-amputation ache.
That very same 12 months, the corporate closed a $10 million Collection A fairness funding spherical, and in 2021, it secured $5 million in pre-Collection A fairness funding.
